Structured evaluation of adrenal gland tumors found incidentally during imaging studies.
- Conditions
- adrenal incidentalomaadrenocortical carcinomaurinary steroid profiling
- Registration Number
- NL-OMON22990
- Lead Sponsor
- niversity Medical Center GroningenAmsterdam Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
adrenal mass > 1 cm in diameter incidentally discovered during CT-scanning, performed for reasons other than an evaluation for adrenal disease
- age 18 years or older
Exclusion Criteria
- extra-adrenal malignancy (i.e. active or past medical history of malignancy, except
for basal cell carcinoma)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter is the difference in cost-effectiveness of the current management strategy based on repeat CT-scanning to detect adrenocortical carcinoma among patients with an adrenal incidentaloma compared with a strategy using a single baseline urinary steroid profiling.
- Secondary Outcome Measures
Name Time Method • frequency of adrenocortical carcinoma among patients with an adrenal incidentaloma at baseline or during follow-up.<br><br /><br>• determination of the percentage of adrenal incidentaloma that fulfils the criteria of a malignant CT-phenotype at baseline or during follow-up.<br><br /><br>• determination of the pathologic diagnosis in patients who underwent adrenalectomy.<br><br /><br>• QoL in patients with an adrenal incidentaloma at baseline and during follow-up.<br><br /><br>• frequency distribution between hormonal hypersecreting and non-functional adrenal incidentaloma.<br><br /><br>• conversion rate of a non-functioning adrenal incidentaloma towards a hypersecreting adrenal incidentaloma during follow-up.<br><br /><br>• costs of diagnostic procedures and surgical interventions.